510(k) Report

Devices descending from K013365

1,127 later devices reach Prolite Pulsed Light System for the Treatment of Pigmented Lesions and the… through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+5K203299CellFX SystemPulse Biosciences, Inc.20214—
+5K201594Primelase ExcellenceHigh Technology Products S.L.U20202—
+5K193201BTL-785FBtl20208—
+5K201064V30 System, V20 System, V10 System, V-FR HandpieceViora, Ltd.20200—
+5K200746IPL Treatment SystemsShanghai Apolo Medical Technology Co., Ltd.20205—
+5K200118Diode Laser Therapy DeviceShanghai Apolo Medical Technology Co., Ltd.20201—
+5K193661LightWalker Laser System FamilyFotona D.O.O.20208—
+5K193367elysion-proHigh Technology Products S.L.U20203—
+5K193446Bare: 808Luvo Medical Technologies, Inc.20202—
+5K191942MT One DiamondM&T S.R.L.20191—
+5K190319Waterlase Laser System FamilyBiolase, Inc.201919—
+5K191554LightWalker Laser System FamilyFotona D.O.O.201919—
+5K191321Primelase ExcellenceHigh Technology Products S.L.U20198—
+5K191611Diode Laser Therapy SystemsWingderm Electro-Optics, Ltd.201901
+5K182930PerioLase Nd:YAG Pulsed Dental Laser SystemMillennium Dental Technologies, Inc.20190—
+5K180359BTL-FR2000BTL Industries, Inc.20189—
+5K181510Echolaser X4El.En Electronic Engineering Spa20183—
+5K172273308nm Excimer SystemChongqing Peninsula Medical Technology Co., Ltd.20185—
+5K180518GME LinScan Lite 808 Laser SystemGme German Medical Engineering GmbH20181—
+5K180189InMode System with Fractora3D/3D-90 ApplicatorsInmode MD, Ltd.201838—
+5K173692D-Actor 200 Vibration Massage SystemStorz Medical AG20186—
+5K173759Thermage CPT System and AccessoriesSolta Medical201821
+5K1730022940 nm Er:Yag Laser HandpieceQuanta System Spa20171—
+5K171702Exciplex308nmClarteis20175—
+5K170758Thermage FLX System and AccessoriesSolta Medical201713—
+5K171359Pollogen Legend+ SystemPollogen, Ltd.20174—
+5K170060M22 and ResurFx SystemsLumenis, Ltd.201724—
+5K162556Lightfusion Led SystemVitage Led, Ltd.20170—
+5K162363V30 system, V-Form Handpiece BC Medium applicatorViora, Ltd.20163—
+5K160312Fraxis DuoIlooda Co,., Ltd.201614—
+5K160075Accent XLAlma Lasers, Inc.20160—
+5K161669Waterlase ExpressBiolase, Inc.201621—
+5K152737Lite TouchFocus Medical, LLC20160—
+5K160195Forma System, Forma Light SystemFormatk Systems, Ltd.20160—
+5K153566Magma SystemFormatk Systems, Ltd.20162—
+5K160368EVO platformQuanta System Spa201636—
+5K151273InMode FRF ApplicatorInmode MD, Ltd.20163—
+5K151890Medical Diode Laser SystemsWuhan Gigaa Optronics Technology Co., Ltd.20153—
+5K151306SoleaConvergent Dental, Inc.20151—
+5K151655CO2RE SystemSyneron Medical, Ltd.20151—
+5K150907Ellipse Nordlys/Ellipse Nordlys+, Ellipse Sirius, Ellipse Infinity, Ellipse Mjolner…Ellipse A/S20155—
+5K150161Venus Viva SR DeviceVenus Concept, Ltd.20159—
+5K143519The MeDioStar NeXT FamilyAsclepion Laser Technologies GmbH201532—
+5K142256Applied BioPhotonics Phototherapy System ABPT1003Applied Biophotonics, Ltd.20150—
+5K142910Legacy BXVenus Concept USA, Inc.201411—
+5K142093V20 SystemViora, Ltd.201432—
+5K140727Cutera Picosecond Laser SystemCutera, Inc.201447—
+5K133945Cutera Picosecond Laser SystemCutera, Inc.201414—
+5K133364Picosure WorkstationCynosure, Inc.201451—
+5K131757Tattoostar Effect ComboAsclepion Laser Technologies GmbH20140—
+5K140629Venus Swan (MP)2Venus Concept, Ltd.20140—
+5K140255Stop U (Packed Black Usa); Stop U (Packed White Usa)Pollogen, Ltd.20147—
+5K133319ET Lightsheer 1060, High Speed Lightsheer 1060Lumenis, Ltd.201424—
+5K133254Revlite Q-Switched ND:Yag Laser SystemCynosure, Inc.201457—
+5K132989Speed 808 Diode Laser SystemBeijing Toplaser Technology Co., Ltd.20140—
+5K131837CO2 Fractional LaserBeijing Honkon Technologies Co., Ltd.20140—
+5K133283Candela Gentlemax Family of Laser SystemsCandela Corp.201313—
+5K131758Surgen UPollogen, Ltd.20135—
+5K131095Deka Synchro Repla: Y Family of Laser SystemsEl.En Electronic Engineering Spa201317—
+5K130199Clarity LPC Laser SystemLutronic Corporation20135—
+5K131859Multifunctional SeriesBeijing Honkon Technologies Co., Ltd.20133—
+5K120510TranscendSyneron Medical, Ltd.201318—
+5K130420SOLEAConvergent Dental, Inc.201321
+5K130193Fraxel Dual 1550/1927 Laser SystemSolta Medical, Inc.201325—
+5K123971Cynosure 1064NM Diode LaserCynosure, Inc.201325—
+5K123573Youlaser CO2 LaserQuanta System Spa201319—
+5K122966XP200Btl Industries, Ltd.20131—
+5K123435Ipl Therapy SystemBeijing Sincoheren S&T Development Co, Ltd.20130—
+5K122995Intense Pulsed Light (Ipl) SystemsBeijing Kes Biology Technology Co., Ltd.201316—
+5K122237Biophotas LifelightBiophotas, Inc.201371—
+5K123257Emvera DioluxEmvera Technologies, Inc.20123—
+5K121346Picosure WorkstationCynosure, Inc.201287—
+5K121286EPIC 10Biolase Technology, Inc.201231—
+5K120377Adverl Evo ER: Yag Laser for Dentistry Mey-1-aJ. Morita USA, Inc.20122—
+5K110333Naturalase CO2 Laser SystemFocus Medical, LLC20121—
+5K120433Clear + Brilliant Laser SystemSolta Medical, Inc.20121—
+5K113588Spectra Laser SystemLutronic Corporation201282—
+5K111286Quasar CalypsoSilver Bay, LLC201276—
+5K110364Dornier Medilas D Litebeam+ 1470Dornier Medtech America, Inc.20117—
+5K111840Emerge Fractional LaserPalomar Medical Products, Inc.20113—
+5K103547Lightlas Multi-Wavelength Medical Laser SystemLightmed Corp.20112—
+5K112253Ceralas 147NM Diode Laser SystemBiolitec, Inc.201118—
+5K112031Alma Lasers Modified Diode Laser Module with SHR Treatment Mode for Use with the Family…Alma Lasers, Inc.2011118—
+5K110907Palomar Icon (TM) Aesthetic SystemPalomar Medical Technologies, Inc.201157—
+5K110349Clear+Brilliant Laser SystemSolta Medical, Inc.20116—
+5K103664Primus Aesthetic PlatformPalomar Medical Technologies, Inc.20117—
+5K101901Ipl Therapy SystemBeijing Starlight Science & Technology Development20110—
+5K102857Ahwon's Ipl SystemAhwon Medi Instrument Co., Ltd.20112—
+5K102698Pelleve Glidesafe Non-Ablative Wrinkle Treatment System Model Pelleve GlidesafeEllman Int'L, Inc.201139—
+5K100726Ceralas D/ 980NM Fiber-Coupled Diode Laser Family, Ceralas E/ 980NM Fiber-Coupled Diode…Biolitec, Inc.201054—
+5K102368Non-Ablative Wrinkle Treatment HandpieceEllman Int'L, Inc.201052—
+5K101152Naturalase Diode Laser Family Naturalase Model NL980, Naturalase Diode Laser Family…Focus Medical, LLC20100—
+5K100558Quanta Diode Laser SystemQuanta System Spa201068—
+5K100270Artisan Aesthetic SystemPalomar Medical Technologies, Inc.2010157—
+5K082230Vectra Plus Laser System and AccessoriesXintec Corporation2010112—
+5K091115ECO2 Laser SystemLutronic Corporation200927—
+5K090639EXELO2, Model 4010Quantel Derma GmbH20090—
+5K091446Modification to LUX1540 Handpiece and Lux 1440 HandpiecePalomar Medical Products, Inc.2009158—
+5K092195Cutera Multimodal Cellulite Product (Cmmcd)Cutera, Inc.20090—
+5K091059Foxq 980 LaserA.R.C Laser GmbH20090—